Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-24 @ 4:05 PM
NCT ID:
NCT03479866
Eligibility Criteria:
Inclusion Criteria:
* Participant eligibility includes those aged \>18 years who have a body mass index (BMI) between 20 and 49.9 kg/m2.
* Eligibility within a subgroup of participants undergoing the home-based intervention (n=1,100) will require participants to be 18-65 years of age.
* Eligibility within a further subgroup of participants undergoing cardiometabolic phenotyping (n=50) will require participants to be \>55 years of age.
Exclusion Criteria:
* Refuse or are unable to give informed consent to participate in the study
* Have ongoing inflammatory disease ie RA, SLE, polymyalgia and other connective tissue diseases.
* Have had cancer in the last three years, excluding skin cancer.
* Have had long term gastrointestinal disorders including inflammatory bowel disease (IBD) or Coeliac disease (gluten allergy), but not including IBS.
* Are taking the following daily medications: immunosuppressants, antibiotics in the last three months.
* Are long-term users of PPIs (such as omeprazole and pantoprazole), unless they are able to stop two weeks before the start of the study and remain off them during the two weeks of the study.
* Have type I diabetes mellitus or are taking medications for type II diabetes mellitus. Those not on medications but having a capillary glucose level of \>12mmol/l based on HemoCue will be excluded. Screening blood results will be shared with their GP after the study.
* Are currently suffering from acute clinically diagnosed depression.
* Have had a heart attack (myocardial infarction) or stroke in the last 6 months.
* Are pregnant
* Are vegan, suffering from an eating disorder or unwilling to take foods that are part of the study.
For participants continuing onto the home-based intervention (n=2,000), the additional following exclusions apply:
* Do not have a mobile phone capable of running the digital app, or are unable to use it to operate the app.
* Have an allergy to adhesives which would prevent proper attachment of the continuous glucose monitor.
For participants undergoing cardiometabolic phenotyping and XMRI (n=50), the additional following exclusions apply:
* Are \<55 years of age
* Are not female
* Have any kind of non-removable materials on their person that are not permitted under MR imaging.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03479866
Study Brief:
Protocol Section:
NCT03479866